Label: SIGNATURE CARE ANTIBACTERIAL FOAMING HAND PEAR SCENT- triclosan soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 11, 2016

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  • Active ingredient

    Triclosan 0.46%

    Purpose

    Antibacterial

  • Uses

    for handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only

    When using this product

    avoid contact with eyes. If eye contact occurs, rinse eyes thoroughly with water.

    Stop using this product and ask a doctor if

    irritation or redness develops

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Pump onto dry hands
    • Lather vigorously for at least 15 seconds
    • Rinse and dry thoroughly
  • Other information

    store at room temperature.

  • Inactive ingredients

    Water (Aqua), Sodium Laureth Sulfate, Sodium Xylenesulfonate, Cocamidopropyl Betaine, PEG-8, Fragrance (Parfum), Disodium Phosphate, Citric Acid, Sodium PCA, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Green 3 (CI 42053), Yellow 10 (CI 47005).

  • Questions or comments?

    1-888-723-3929

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE ANTIBACTERIAL FOAMING HAND PEAR SCENT 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN4.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-114-07222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/10/2016
    Labeler - SAFEWAY INC (009137209)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(21130-114)
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